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Bang, Yung-Jue,Cho, Jae Yong,Kim, Yeul Hong,Kim, Jin Won,Di Bartolomeo, Maria,Ajani, Jaffer A.,Yamaguchi, Kensei,Balogh, Agnes,Sanchez, Teresa,Moehler, Markus American Association for Cancer Research 2017 Clinical Cancer Research Vol.23 No.19
<P><B>Purpose:</B> Ipilimumab, a monoclonal antibody that blocks cytotoxic T-lymphocyte–associated protein-4 interactions, enhances T-cell activation and promotes tumor immunity. This phase II study evaluated the safety and efficacy of ipilimumab monotherapy versus best supportive care (BSC) among patients with advanced/metastatic gastric or gastroesophageal junction cancer who achieved at least stable disease with first-line chemotherapy.</P><P><B>Experimental Design:</B> Eligible patients were randomized to ipilimumab 10 mg/kg every 3 weeks for four doses, then 10 mg/kg every 12 weeks for up to 3 years, or BSC, which could include continuation of fluoropyrimidine until progression or toxicity. The primary endpoint was immune-related progression-free survival (irPFS); secondary endpoints included PFS by modified World Health Organization criteria and overall survival (OS).</P><P><B>Results:</B> Of 143 patients screened, 57 were randomized to each arm. irPFS with ipilimumab versus BSC was not improved [2.92 months, 95% confidence interval (CI), 1.61–5.16 vs. 4.90 months, 95% CI, 3.45–6.54, HR = 1.44; 80% CI, 1.09–1.91; <I>P</I> = 0.097], resulting in study cessation. At study closeout, which occurred 8 months after the interim analysis, the median OS durations were 12.7 months (95% CI, 10.5–18.9) and 12.1 months (95% CI, 9.3–not estimable), respectively. Grade 3/4 treatment-related adverse events occurred in 23% of ipilimumab-treated patients, in whom diarrhea (9%) and fatigue (5%) were most frequent, and in 9% of active BSC-treated patients.</P><P><B>Conclusions:</B> Although ipilimumab at 10 mg/kg was manageable, it did not improve irPFS versus BSC. However, comparable median OS of approximately 1 year and a favorable safety profile support the investigation of ipilimumab in combination with other therapies for advanced gastric cancer. <I>Clin Cancer Res; 23(19); 5671–8. ©2017 AACR</I>.</P>
Kim, Kyung Won,Lee, Jeong Min,Jeon, Yong Sik,Kang, Sung Eun,Baek, Jee Hyun,Han, Joon Koo,Choi, Byung Ihn,Bang, Yung-Jue,Kiefer, Berthold,Block, Kai Tobias,Ji, Hyunjun,Bauer, Simon,Kim, Chin Springer International 2013 European radiology Vol.23 No.5
<P>To evaluate the feasibility of free-breathing, dynamic contrast-enhanced (DCE) MRI of the abdomen and thorax using the radial-gradient-echo sequence with k-space weighted image contrast (KWIC) reconstruction.</P>
( Do Youn Oh ),( Yu Jung Kim ),( Yung Jue Bang ),( Jee Hyun Kim ),( In Sil Choi ),( Sae Won Han ),( Seock Ah Im ),( Kyung Hun Lee ),( Tae You Kim ),( Keun Wook Lee ),( Tae Yong Kim ) 대한내과학회 2014 대한내과학회 추계학술대회 Vol.2014 No.1
Background: To investigate the effi cacy of gemcitabine plus UFT (uracil-tegafur) combination chemotherapy as a salvage treatment in patients with metastatic colorectal cancer (MCRC) Methods: This single-arm phase 2 study was conducted at 3 institutions in Korea. Patients with MCRC refractory to fiuoropyrimidine, oxaliplatin and irinotecan were enrolled. Gemcitabine 800 mg/m2 was administered intravenously on days 1, 8 and 15.UFT 200 mg/m2/day was taken orally in 3 divided doses on days 1-21. Cycles were repeated every 4 weeks and tumor evaluation was carried out every 8 weeks. The primary endpoint of this study was 8-week progression-free survival (PFS) rate. Results: Forty-one patients were enrolled. Fourteen patients received gemcitabine/UFT as a third-line treatment and 37 patients as a 4th-line or later-line therapy. Toxicities were easily manageable and non-hematologic toxicities of = grade 3 were rare. The most common toxicity of = grade 3 was neutropenia (20.0%). One patient showed partial response (response rate, 2.4%) and 14 (34.1%) showed stable disease. The 8-week PFS rate was 42.3%. The median PFS was 1.7 months [95% confi dence interval (CI), 1.6-1.8 months] and the median OS was 9.2 months (95% CI, 5.8-12.6 months). Conclusions: Overall effi cacy of gemcitabine/UFT in refractory MCRC was unsatisfactory. However, we could found a minor proportion of patients who showed prolonged tumor stabilization to gemcitabine/UFT. Further studies are warranted to identify a patient subgroup that might have benefi ts from gemcitabine/UFT therapy.